Dispute to Clarify Whether Patent Certification and Exchange Process in Section 351(2) of the Public Health Service Act is Mandatory or Permissive

A recent suit between Amgen and Sandoz may serve to clarify certain an important provision governing patent disputes of the Biologics Price Competition and Innovation Act (BPCIA). Amgen is the owner of a Biologics License Application (BLA) for the drug Neupogen, and Sandoz recently filed a 351(k) application for a biosimilar of the drug (Biosimilars are the equivalent of generic small molecule drugs in field of “large molecule” therapeutics).

Apparently, Sandoz has taken the position that the patent exchange process in Section 351(1) of the BPCIA is a matter of discretion. This position contrasts with provisions of the BPCIA which require that an applicant for a biosimilar provide the Reference Product sponsor a copy of the application within 20 days of notice from the FDA that the application has been accepted for review. Amgen notes that the statute itself states that an applicant “shall” do so.

Whether the court decides to clarify the resolution by requiring a certification be added to forms filed with BLAs or by other means will serve to illuminate an important provision of the BPCIA governing patent disputes between sponsors and biosimilar applicants.